FDA 510(k) Applications for Medical Device Product Code "DHR"
(System, Test, Rheumatoid Factor)

FDA 510(k) Number Applicant Device Name Decision Date
K850373 ABBOTT LABORATORIES ABBOTT RF EIA DIAGNOSTIC KIT 03/01/1985
K990035 ABBOTT LABORATORIES RF 03/08/1999
K024067 ABBOTT LABORATORIES RHEUMATOID FACTOR (RF) 01/15/2003
K920220 AKERS RESEARCH CORP. HEALTHTEST RHEUMATOID FACTOR ASSAY 03/13/1992
K880164 AMPCOR, INC. RF CARD TEST & RF LIQUID TEST 02/10/1988
K873064 AMTEC DIAGNOSTICS INTERNATIONAL, INC. AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT 11/04/1987
K812882 ARMKEL, LLC. RHEUMATEX 10/26/1981
K821941 ARMKEL, LLC. RHEUMATOID FACTOR REFERENCE PREPARA. 08/27/1982
K800268 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC AUTOMATED RHEMATOID FACTOR TEST (ARFT) 02/21/1980
K802688 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RHEUMATOID FACTOR TEST SYSTEMS 12/18/1980
K760043 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC TEST, RHEUM. ARTH., CARD (MACRO-VUE) 08/03/1976
K971602 BECKMAN INSTRUMENTS, INC. ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT 06/27/1997
K963048 BECKMAN INSTRUMENTS, INC. IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT 11/04/1996
K810306 BECKMAN INSTRUMENTS, INC. RHEUMATOID FACTOR REAGENT TEST KIT 03/11/1981
K971788 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR 06/03/1997
K851537 BEHRING DIAGNOSTICS, INC. LASER RF CONTROL SERUM-QUALITY CONTROL SERUM 06/05/1985
K850296 BEHRING DIAGNOSTICS, INC. LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS 04/12/1985
K942328 BEHRING DIAGNOSTICS, INC. N LATEX RF 10/20/1994
K903852 BEHRING DIAGNOSTICS, INC. RAPITEX(R) RF NEW 08/30/1990
K920124 BEHRING DIAGNOSTICS, INC. TURBIQUANT 03/02/1992
K990587 BIO-RAD ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01 04/07/1999
K923578 BIO-RAD LIQUICHEK RHEUMATOID FACTOR CONTROL 10/06/1992
K960987 BIO-RAD LIQUICHEK RHEUMATOID FACTOR CONTROL 06/04/1996
K896271 BIOKIT USA, INC. QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) 11/08/1989
K904310 BIOKIT USA, INC. RHEUMAGEN RF T-CONTROL 05/31/1991
K910539 BIOKIT USA, INC. RHEUMAJET RF 04/05/1991
K811375 BIOLOGICS INTL., INC. BI-RA SLIDE TEST 06/12/1981
K892444 BIOSEARCH MEDICAL PRODUCTS, INC. REAADS-RF TEST KIT-QUANTITATIVE 06/05/1989
K892445 BIOSEARCH MEDICAL PRODUCTS, INC. REAADS-RF TEST KIT-SEMIQUANTITATIVE 06/05/1989
K863238 BIOSTAR MEDICAL PRODUCTS, INC. READS RF TEST KIT FOR IGM RHEUMATOID FACTOR 10/08/1986
K904498 BIOTRAX, INC. CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST 10/29/1990
K920753 BIOWHITTAKER MOLECULAR APPLICATIONS, INC. RF STAT IGM TEST KIT 03/30/1992
K971379 BOEHRINGER MANNHEIM CORP. TINAQUANT RHEUMATOID FACTOR ASSAY 06/17/1997
K851099 BREIT LABORATORIES, INC. IGM RHEUMATOID FACTOR TEST KIT 04/25/1985
K810404 CALBIOCHEM-BEHRING CORP. RHEUMATOID FACTORS REFERENCE SERUM 03/11/1981
K790012 CALBIOCHEM-BEHRING CORP. RHEUMOGEN TEST SYSTEM 01/26/1979
K790351 CENTRAL BIOLOGICAL CO. RHEUMATELL 03/15/1979
K924056 CLARK LABORATORIES, INC. ENCORE RHEUMATOID FACTOR EIA 09/25/1992
K993557 COGENT DIAGNOTICS LTD. AUTOSTAT II RHEUMATOID FACTOR IGA ELISA 03/03/2000
K993304 COGENT DIAGNOTICS LTD. AUTOSTAT II RHEUMATOID FACTOR IGG ELISA 12/06/1999
K994338 COGENT DIAGNOTICS LTD. AUTOSTAT II RHEUMATOID FACTOR IGM ELISA 02/03/2000
K961545 CONSOLIDATED TECHNOLOGIES, INC. QUALITROL RF CONTROLS 09/24/1996
K831941 COOPER DIAGNOSTICS, INC. LEAP RHEUMATOID FACTOR TEST KIT 07/18/1983
K792061 CORDIS CORP. CORDIA RF 11/27/1979
K071247 DADE BEHRING, INC. N LATEX RF KIT 08/08/2007
K843896 DIAGNOSTIC PRODUCTS CORP. RHEUMADX LATEX AGGLUTINATION RHEUMATOID 10/25/1984
K840049 DIAGNOSTIC PRODUCTS CORP. SOPHEIA MP IGM RHEUMATOID FACTOR EIA 02/10/1984
K831467 DIAGNOSTIC TECHNOLOGY, INC. RA-CHECK 06/08/1983
K974889 DIAMEDIX CORP. DIAMEDIX IS-RF TEST SYSTEM 03/06/1998
K021394 DIAMEDIX CORP. DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM 07/09/2002
K871041 DIAMEDIX CORP. RF MICROASSAY 03/31/1987
K841454 DIFCO LABORATORIES, INC. RF TEST KIT 04/25/1984
K830832 EMD CHEMICALS INC. RHEUMATOID FACTOR-RAPID CARD TEST #65114 04/18/1983
K822905 FISHER SCIENTIFIC CO., LLC. LATEST RF KIT FOR RHEUMATOID FACTOR 10/18/1982
K760036 GAMMA BIOLOGICALS, INC. TEST, LATEX SLIDE, RHEUMATOID FACTOR 08/03/1976
K960703 GLOBE MANAGEMENT SUPPORT, INC. RF-LATEX SEIKEN REAGENT SYSTEM 04/19/1996
K962836 HEMAGEN DIAGNOSTICS, INC. HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) 09/12/1996
K855221 HEMAGEN DIAGNOSTICS, INC. SERATEST RF (HEMAGGLUTINATION) KIT 04/22/1986
K970373 HENAGE DIAGNOSTICS, INC. RAICHEM RHEUMATOID FACTOR SPIA 04/17/1997
K962729 HYCOR BIOMEDICAL, INC. HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY 03/07/1997
K954892 HYCOR BIOMEDICAL, INC. HYTEC AUTOMIMMUNE KIT (RF) 12/26/1995
K771552 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES LAS-R RHEUMATOID FACTOR TEST 08/30/1977
K942272 IMMCO DIAGNOSTICS, INC. IGM RHEUMATOID FACTOR 09/26/1994
K143736 IMMCO DIAGNOSTICS, INC. ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA 09/23/2015
K801961 IMMUNO-DIAGNOSTIC PRODUCTS, INC. RF-II TEST KIT 10/10/1980
K926569 IMMUNOSTICS CO., INC. IMMUNO RA UNDILUTED 04/06/1993
K834391 IMMUNOSTICS CO., INC. IMMUNO-RA 02/03/1984
K972456 IMMUNOSTICS, INC. RHEUMACOL RHEUMATOID FACTOR TEST 11/25/1997
K983084 INOVA DIAGNOSTICS, INC. QUANTA LITE RF IGA ELISA 11/04/1998
K983083 INOVA DIAGNOSTICS, INC. QUANTA LITE RF IGG ELISA 11/04/1998
K971614 INOVA DIAGNOSTICS, INC. QUANTA LITE RF IGM 06/20/1997
K973464 INSTRUMENTATION LABORATORY CO. QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) 10/22/1997
K812968 INTL. DIAGNOSTIC TECHNOLOGY FIAX RHEUMATOID FACTOR TEST KIT 11/06/1981
K840005 INTL. DIAGNOSTIC, INC. NABI RF-Q.S. TEST 02/13/1984
K932437 J & S MEDICAL ASSOC., INC. EYE SPOT RF TEST 08/23/1993
K924036 J.S. MEDICAL ASSOC. ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST 12/01/1992
K902462 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. MODIFIED QM300 RHEUMATOID FACTOR TEST 06/21/1990
K883538 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 CALIBRATOR E PACK 09/07/1988
K883536 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 RHEUMATOID FACTOR ANTIGEN PACK 09/07/1988
K991409 KAMIYA BIOMEDICAL CO. K-ASSAY RHEUMATOID FACTOR 06/09/1999
K991467 KAMIYA BIOMEDICAL CO. K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET 06/10/1999
K984045 KAMIYA BIOMEDICAL CO. RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS 01/25/1999
K964418 KAMIYA TECHNOLOGY SERVICES N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET 12/13/1996
K964415 KAMIYA TECHNOLOGY SERVICES N-ASSAY TIA RHEUMATOID FACTOR TEST KIT 12/13/1996
K874151 LIPOGEN, INC. RF DIPSTICK TEST KIT 12/29/1987
K854222 MARVIC INTERPHARMA, INC. DIESSE RF TEST KIT 02/06/1986
K792695 MERIDIAN DIAGNOSTICS, INC. ANTI-GLOBULIN CONTROL 01/24/1980
K792697 MERIDIAN DIAGNOSTICS, INC. NORMAL GLOBULIN REAGENT 01/24/1980
K993843 MICRO DETECT, INC. MDI RF TEST 01/11/2000
K841146 NCS DIAGNOSTICS, INC. NCS RA LATEX TEST 04/20/1984
K060201 OLYMPUS AMERICA, INC. OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. 06/06/2006
K953520 OLYMPUS AMERICA, INC. OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT 08/24/1995
K771940 ORGANON, INC. QUANTROLS RF 11/02/1977
K771410 ORGANON, INC. RHEUMANOSTICON R 09/02/1977
K100499 ORGENTEC DIAGNOSTIKA GMBH ORGENTEC RHEUMATOID FACTOR EIA 10/27/2010
K871196 ORION DIAGNOSTICA, INC. RHEUMA-CHECK ENZYME IMMUNOASSAY TEST 05/06/1987
K041863 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS 09/20/2004
K812972 OXOID U.S.A., INC. RA LATEX TEST 11/06/1981
K102673 PHADIA US INC. RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM 09/30/2011
K955086 POLYMEDCO, INC. TEST, RHEUMATOID FACTOR 12/20/1995
K853054 PRECO, INC. RF CARD TEST 08/01/1985
K923771 PULSE SCIENTIFIC, INC. PULSE RF TEST 10/05/1992
K961169 RANDOX LABORATORIES, LTD. RHEUMATOID FACTOR LATEX SLIDE TEST KIT 06/26/1996
K972220 RANDOX LABORATORIES, LTD. RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT 09/09/1997
K000534 ROCHE DIAGNOSTICS CORP. COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II 04/05/2000
K032535 ROCHE DIAGNOSTICS CORP. MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM 09/10/2003
K002609 ROCHE DIAGNOSTICS CORP. TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM 09/05/2000
K873782 SCLAVO, INC. REUMA TEST 11/27/1987
K810221 SCRIPPS-MILES, INC. SCRIPPSERA THEUMATOID FACTOR REFER. CNTL 02/09/1981
K810141 SCRIPPS-MILES, INC. SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT 02/09/1981
K981496 SERADYN, INC. COLOR-SLIDE RF 06/15/1998
K840863 SERAGEN DIAGNOSTICS, INC. SERATEST RF LATEX DETERMINATION 04/04/1984
K953261 SHARED SYSTEMS, INC. CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM 08/15/1995
K942908 SIGMA DIAGNOSTICS, INC. IGM RF EIA 01/20/1995
K922725 SIMPLICITY DIAGNOSTICS, INC. TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL 10/05/1992
K083080 SQI DIAGNOSTICS SYSTEMS IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM 10/29/2009
K974370 STANBIO LABORATORY RAPET RF 02/17/1998
K813309 SUN-KIT RA-80 POSITIVE CONTROL 12/17/1981
K854820 SYN-KIT, INC. RA 80 "EIKEN" 01/17/1986
K802448 SYN-KIT, INC. RA 80 EIKEN KIT DETERM. OF RHEUMATIC F. 01/05/1981
K830611 TAGO, INC. RA SCREENING TEST 03/24/1983
K894574 TECHNICON INSTRUMENTS CORP. TECHNICON DPA-1 SYSTEM RF METHOD 08/10/1989
K962015 TECO DIAGNOSTICS RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST 11/25/1996
K831597 TEXAS IMMUNOLOGY, INC. SERO/TEX RED CELL RF TEST 06/30/1983
K821319 TEXAS IMMUNOLOGY, INC. SERO/TEX RF TEST 05/21/1982
K904105 TEXAS IMMUNOLOGY, INC. V-TREND TARGET RF TEST 10/15/1990
K041891 THE BINDING SITE MININEPH HUMAN RHEUMATOID FACTOR KIT 11/05/2004
K162263 THE BINDING SITE GROUP LTD. Optilite Rheumatoid Factor Kit 05/03/2017
K160070 THE BINDING SITE GROUP, LTD. Rheumatoid Factor (RF) Kit for use on SPAPLUS 12/07/2016
K933712 THERATEST LABORATORIES, INC. EL-RF TEST SYSTEM: EL-RF-IGM KIT 01/28/1994
K941398 THERATEST LABORATORIES, INC. EL-RF/3 (IGM-IGG-IGA) KIT 07/28/1995
K962050 THERATEST LABORATORIES, INC. THERATEST EL-RFSCR 12/16/1996
K915320 TRINITY LABORATORIES, INC. RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST 12/07/1992
K884180 UNIPATH LTD. TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM 02/03/1989
K883355 UNITED BIOTECH, INC. UBI MAGIWEL RF-IGM QUANTITATIVE 09/07/1988
K791507 VOLU SOL MEDICAL INDUSTRIES AGGLUTINOTEST-RHEUMATOID ARTHRITIS 12/31/1979
K922151 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT RF 07/28/1992
K020972 WAKO CHEMICALS, USA, INC. WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET 09/09/2002
K033802 ZEUS SCIENTIFIC, INC. ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM 02/27/2004
K961277 ZEUS SCIENTIFIC, INC. RF IGM ELISA TEST SYSTEM 05/08/1996
K983418 ZEUS SCIENTIFIC, INC. THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL 11/18/1998


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact